Catalog Number

M202

Brand Name

AmpliVue

Version/Model Number

GBS Assay

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K133503

Product Code

NJR

Product Code Name

Nucleic acid amplification assay system, group b streptococcus, direct specimen test

Public Device Record Key

aab63298-b2df-4848-9c07-25a65dd96b91

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

August 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-